BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821438 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00309
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS REC'D BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS REC'D IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS ON THE LID. THERE WERE GOUGES IN THE CART ON THE LOWER CASE AND SCRATCHES ON THE FRONT PANEL. THE BOTTOM NYLON SCREW WAS CLEAVED OFF. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS AND RECOGNIZED BOTH THE PT RETURN PAD CONNECTION AND THE HAND PIECE CONNECTION. THE F6 FAULT OCCURS WHEN THE COMMUNICATION BETWEEN THE UCB AND RF CONTROLLER GETS GARBLED. REBOOTING CLEARS THIS FAULT. THIS IS ADDRESSED BY TWISTING THE WIRES IN THE UCB-TO-RF CONTROLLER CABLE HARNESS. THE UNIT WAS REPAIRED. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MASTECTOMY CASE, THE ERROR CODE F6 APPEARED, THE SYSTEM HAD TO BE REBOOTED. THERE WAS NO PT IMPACT. SECOND FIRST OF 2 EVENTS; SEE 3007069406-2012-00308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR GENERATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE